NCT04849793

Brief Summary

This randomized controlled study evaluates the effect of acupressure application on the anxiety level of senior nursing students.The hypothesis of this study is that acupressure reduces anxiety levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1 month

First QC Date

April 8, 2021

Last Update Submit

November 10, 2022

Conditions

Keywords

AcupressureNursing studentsAnxietyCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Anxiety evaluated using the State Anxiety Scale

    Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high

    Change from before implementation and 4th week of practice

Secondary Outcomes (1)

  • Anxiety evaluated using the Trait Anxiety Scale

    Change from before implementation and 4th week of practice

Study Arms (2)

Experimental

EXPERIMENTAL

Before the intervention, the students will be asked to rub the area around the area to be pressed for 20-30 seconds with their palms. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in the area of warming, relaxing and preparatory will be reduced and the tissue will be relieved. After rubbing, each individual's pain threshold level will be taken as a basis in order not to cause tissue damage. The students will be asked to press the designated point manually with their thumb, index or middle finger for 5 seconds with a depth of 1-1.5 cm, rest for 2 seconds and continue the practice for 2 minutes. In the study group, an average of 13 minutes will be applied to HT7, LI4 and EX-HN3 points (five points in total) for two minutes each. The nursing students participating in the research will be given a total of 12 acupressure intervention remotely, three days a week, for four weeks, at least two hours after dinner and when they are calmest.

Other: Acupressure

Control

NO INTERVENTION

No intervention will be made to the control group, only the data will be collected at the same time as the study group.

Interventions

Before starting the application, the students will be asked to rub the area around the area to be pressed for 20-30 seconds with their palms. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in the area of warming, relaxing and preparatory will be reduced and the tissue will be relieved. . The students will be asked to press the designated point manually with their thumb, index or middle finger for 5 seconds with a depth of 1-1.5 cm, rest for 2 seconds and continue the practice for 2 minutes

Also known as: Acupress
Experimental

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The experimental group criteria to be included in the study;
  • To voluntarily agree to participate in the study (those who signed the Informed Volunteer Form),
  • Not having physical problems that would prevent acupressure application to HT7 (wrist), LI4 (the point where the thumb and index finger meet) and EX-HN3 (the middle point of the right and left eye level),
  • Not having experience with acupressure,
  • Not using drugs that affect anxiety level (antidepressants, analgesics, beta adrenoreceptor antagonists, dopamine agonists, etc.),
  • Not using alcohol and drugs,
  • Not having access to the devices required for internet and online education,
  • Not being diagnosed with COVID-19 during the study,
  • Not having any psychiatric diagnosis.,
  • The control group criteria to be included in the study;
  • To voluntarily agree to participate in the study (those who signed the Informed Volunteer Form),
  • Not having experience with acupressure,
  • Not using drugs that affect anxiety level (antidepressants, analgesics, beta adrenoreceptor antagonists, dopamine agonists, etc.),
  • Not having access to the devices required for internet and online education,
  • Not using alcohol and drugs,
  • +2 more criteria

You may not qualify if:

  • The experimental group criteria not to be included in the study;
  • Not accepting voluntarily to participate in the study (those who did not sign the Informed Volunteer Form),
  • Having a physical problem that prevents acupressure application to HT7 (wrist), LI4 (the point where the thumb and index finger meet) and EX-HN3 (the middle point of the right and left eye level),
  • To have an acupressure experience,
  • Using drugs that affect anxiety level (antidepressants, analgesics, beta adrenoreceptor antagonists, dopamine agonists, etc.),
  • Having access to the devices required for internet and online education,
  • Using alcohol and substance,
  • Being diagnosed with COVID-19 during the study,
  • Any psychiatric diagnosis
  • The control group criteria not to be included in the study;
  • Not accepting voluntarily to participate in the study (those who did not sign the Informed Volunteer Form),
  • To have an acupressure experience,
  • Using drugs that affect anxiety level (antidepressants, analgesics, beta adrenoreceptor antagonists, dopamine agonists, etc.),
  • Having access to the devices required for internet and online education,
  • Using alcohol and substance,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey, Mersin University,

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersCOVID-19

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Mental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gülay ALTUN UĞRAŞ, Doctorate

    gulaltun@mersin.edu.tr

    STUDY DIRECTOR
  • Seher GÜRDİL YILMAZ, Doctorate

    shrgrdl@hotmail.com

    PRINCIPAL INVESTIGATOR
  • Ahmet KARAMAN, Doctorate

    ahmet.karaman@mersin.edu.tr

    PRINCIPAL INVESTIGATOR
  • Canan KANAT, MASTER

    canankanat@mersin.edu.tr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
First of all, the names of all students will be listed alphabetically for the selection of 196 nursing students in the research population and 52 nursing students who will be the sample. Numbers between 1-196 will be written in front of each student in the ordered student list. 52 nursing students will be determined by randomization created in computer environment by an independent researcher who is not included in the study. A total of 52 students in the sample group determined by randomization will be separated according to the A and B groups created by the same statistician in computer environment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, parallel, two-arm randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 19, 2021

Study Start

April 15, 2021

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations